April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO): 24-Week Results of the VIBRANT Study
Author Affiliations & Notes
  • David S Boyer
    Ophthalmology, Retina Vitreous Assoc Med Group, Los Angeles, CA
  • Footnotes
    Commercial Relationships David Boyer, Alcon (C), Allegro (I), Allergan (C), Allergan (F), Allergan (R), Bausch&Lomb (C), Bayer (C), Genentech (C), Genentech (F), Genentech (R), Regeneron (R), Throbogenics (F), Thrombogenics (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 604. doi:
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      David S Boyer, ; Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO): 24-Week Results of the VIBRANT Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):604.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: The VIBRANT study was conducted to compare the efficacy and safety of IAI with laser photocoagulation for the treatment of macular edema secondary to BRVO.

Methods: VIBRANT was a multicenter, double-masked, active-controlled, randomized, phase 3 trial. Treatment-naïve patients with unilateral macular edema secondary to BRVO were included in the study if they were diagnosed within 12 months and had a BCVA between 73 and 24 letters (20/40 to 20/320 Snellen equivalent). In VIBRANT, patients received either IAI 2 mg every 4 weeks (n = 91) or laser (n = 92) from baseline to week 20. The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. The secondary efficacy endpoints included the mean change from baseline in BCVA and central retinal thickness (CRT) at week 24.

Results: The proportion of patients who gained ≥15 letters from baseline to week 24 was 53% in the IAI group compared with 27% in the laser group (P < .001). The mean improvement in BCVA from baseline to week 24 was 17.0 letters in the IAI group and 6.9 letters in the laser group (P < .0001). The mean reduction in CRT from baseline to week 24 was 280.5 μm in the IAI group and 128.8 μm in the laser group (P < .0001). The most common ocular adverse events in IAI patients were conjunctival hemorrhage (19.8%) and eye pain (4.4%). Over the 24 weeks of the study, traumatic cataract in an IAI patient was the only ocular serious adverse event (SAE) that occurred. The incidence of non-ocular SAEs was 8.8% in the IAI group and 9.8% in the laser group. One death due to pneumonia and one Anti-Platelet Trialists' Collaboration-defined event of non-fatal stroke occurred during the 24 weeks of the study, both in patients in the laser group. There were no cases of intraocular inflammation or endophthalmitis.

Conclusions: Monthly injections of intravitreal aflibercept were well tolerated and significantly improved visual acuity at week 24 in patients with macular edema secondary to BRVO.

Keywords: 688 retina • 749 vascular occlusion/vascular occlusive disease  
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